Comparison between sedative medication combinations Fentanyl -Ketamine and Midazolam -Ketamine for use in sedation in children during flexible bronchoscopy

Not yet recruiting

• Conditions: Other Procedures,

• Registration Number: CTRI/2023/05/052577
• Lead Sponsor: All India Institute of Medical Sciences BHUBANESWAR

Brief Summary

Title : Fentanyl-Ketamine versus Midazolam-Ketamine for sedation in children undergoing flexible fiber-optic bronchoscopy – An open label Randomized Controlled trial

Rationale - Flexible fiberoptic bronchoscopy has become a crucial component in the diagnosis and treatment of acute and chronic pulmonary diseases in paediatric population. Sedation helps to induce and maintain appropriate amnesia, analgesia and muscle relaxation. It controls the behavior and movements of the subject and attenuate undesirable respiratory reflexes during procedure. The antitussive effect of opioids such as Fentanyl makes them more advantageous over other sedative agents like Midazolam for sedation in bronchoscopy.  This study  is  to compare the efficacy of Fentanyl – Ketamine with Midazolam - Ketamine in controlling cough episodes during bronchoscopy and their safety.



Primary Objective :To compare the frequency of severe cough episodes during bronchoscopy in both groups

Secondary Objectives 1. Assess time to achieve Ramsay sedation score 4 after administration of sedative 2. Assess adverse effects of sedatives 3. Assess bronchoscopist satisfaction regarding sedation



Methodology

Study Design: Open Label, Randomized controlled trial

Place of Study: Department of Pediatrics, All India Institute of Medical Sciences, Bhubaneswar

Study Population: children aged 6 months to 15 years admitted to undergo flexible bronchoscopy in the Department of Pediatrics

Randomization- with a computer generated random sequence

Allocation concealment-serially numbered opaque sealed envelope (SNOSE) technique



Intervention: After consent/assent, children allocated to group A will be given Ketamine at dose of 1mg/kg and midazolam at dose of 0.1mg/kg and additional dose of ketamine @1mg/kg will be given on the discretion of bronchoscopist.

Children allocated to group B will be given Ketamine at dose of 1mg/kg and Fentanyl at dose of 1mcg/kg and additional dose of ketamine @1mg/kg will be given on the discretion of bronchoscopist.

Entire bronchoscopy procedure from the time of injection of sedative drugs till the completion of procedure will be videorecorded.

Video of the procedure for severe cough episodes will be reviewed by adult pulmonologist who is not a part of the study.

Adverse effects of sedatives through monitoring vital parameters like heart rate ,respiratory rate,SpO2 and Blood pressure and time required to achieve Ramsay sedation score 4 will be recorded.

Bronchoscopy score is also derived to assess the satisfaction of bronchoscopist regarding sedation.



Statistical Analysis: Data will be entered into MS Excel, and analysis will be done using STATA (College Station, TX, US).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-06
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

All children aged 6 months to 15 years admitted for flexible bronchoscopy in department of Pediatrics, AIIMS Bhubaneswar.

Exclusion Criteria

• Children with difficult airway 2.
• Children with hemodynamic compromise requiring vasoactive inotropic score >10 3.
• Children on respiratory support requiring FiO2>40% or high flow nasal cannula therapy 4.
• Children who require therapeutic procedures using flexible bronchoscopy like endobronchial biopsy, stent placement, balloon dilatation, foreign body removal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of severe cough episodes during bronchoscopy in either group	Time starting from the administration of sedative medications upto 20 minutes of bronchoscopy

Secondary Outcome Measures

Name	Time	Method
1.The time to achieve Ramsay sedation score 4 after administration of medication	2.Adverse effects of medications like hypotension,hypertension,bradycardia,tachycardia,hypoxemia

Trial Locations

Locations (1)

Pediatric OPD Room No. 39 ,Ground floor , All India Institute of Medical Sciences,Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

Pediatric OPD Room No. 39 ,Ground floor , All India Institute of Medical Sciences,Bhubaneswar

🇮🇳Khordha, ORISSA, India

DrKrishna Mohan Gulla

Principal investigator

9582273062

ped_krishna@aiimsbhubaneswar.edu.in